Physiologic simulator system

ABSTRACT

Systems ( 10 ) for the simulation of percutaneous medical procedures are disclosed. The systems can include a simulated vasculature including a first component ( 24 ) configured to allow for introduction of a medical device into the system through an introductory port, a second component ( 14 ) connected to the first component and shaped to simulate a portion of a human vasculature, and a third component ( 18 ) connected to the second component and shaped to simulate a delivery site for the medical procedure. The system can be configured to allow for a medical device to be delivered to the third component by passing through the introductory port of the first component and passing through the second component. The system can be configured to replicate simulated conditions of use for the medical procedure. Methods for simulating a percutaneous medical procedure using a simulated vasculature are also disclosed.

BACKGROUND

Field

Certain embodiments of the present invention are related to physiologicsimulator systems for medical procedures.

Background Art

Medical devices can be delivered to a site within a patient through avariety of techniques. For example, a medical device can be implanted orotherwise delivered through conventional open surgical techniques, suchas for example open-heart surgery. In some techniques, a medical devicecan be implanted or delivered percutaneously. For example, in somepercutaneous techniques, a medical device, such as a valve prosthesiscan be compacted and loaded onto a delivery device for advancementthrough a patient's vasculature in a transfemoral, transapical, ortransatrial procedure. There is a continuous need for physiologicsimulator systems that can be used for training or other purposesrelated to catheter-based medical procedures as well as other deliverytechniques.

SUMMARY

In some embodiments, a system for the simulation of percutaneous medicalprocedures can include a simulated vasculature including a firstcomponent configured to allow for introduction of a medical device intothe system through an introductory port, a second component connected tothe first component and shaped to simulate a portion of a humanvasculature, and a third component connected to the second component andshaped to simulate a delivery site for the medical procedure. The systemcan be configured to allow for a medical device to be delivered to thethird component by passing through the introductory port of the firstcomponent and passing through the second component. The system can beconfigured to replicate simulated conditions of use for the medicalprocedure.

In some embodiments, a method of simulating a percutaneous medicalprocedure can include using a simulated vasculature having a firstcomponent configured to allow for introduction of a medical device intothe system through an introductory port, a second component connected tothe first component and shaped to simulate a portion of a humanvasculature, and a third component connected to the second component andshaped to simulate a delivery site for the medical procedure. The methodcan include inserting a medical device into the introductory port of afirst component, advancing the medical device through the firstcomponent and into a second component, and advancing the medical devicethrough the second component and into a third component.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying figures, which are incorporated herein, form part ofthe specification and illustrate embodiments of a physiologic simulatorsystem. Together with the description, the figures further serve toexplain the principles of and to enable a person skilled in the relevantart(s) to make and use the systems described herein.

FIG. 1 illustrates an embodiment of a physiologic simulator system.

FIG. 2 is a schematic flow diagram of the system of FIG. 1.

FIGS. 3a-d illustrate various views of an embodiment of a firstcomponent of the system of FIG. 1.

FIGS. 4a-d illustrate various views of an embodiment of a base of thesystem of FIG. 1.

FIGS. 5a-d illustrate various views of an embodiment of a secondcomponent of the system of FIG. 1.

FIG. 6a illustrates a view of an embodiment of a third component of thesystem of FIG. 1.

FIGS. 6b-c illustrate various views of another embodiment of a thirdcomponent of the system of FIG. 1.

FIGS. 7a-d illustrate various views of an embodiment of a tank unit ofthe system of FIG. 1.

DETAILED DESCRIPTION

The following detailed description refers to the accompanying figureswhich illustrate several embodiments. Other embodiments are possible.Modifications can be made to the embodiments described herein withoutdeparting from the spirit and scope of the present invention. Therefore,the following detailed description is not meant to be limiting.

FIG. 1 illustrates an embodiment of a physiologic simulator system 10.In some embodiments, system 10 can enable an operator to perform one ormore catheter-based implant procedures under simulated conditions ofuse. System 10 can include a first component 12, a second component 14supported by a base 16, third component 18, tank unit 20, and a pump 22,each of which is described further herein.

As shown in FIG. 1, first component 12 can include an introducer port 24which can allow for the introduction of a device (not shown), such as adelivery catheter. First component 12 is operatively connected to secondcomponent 14 to allow the device to pass through first component and bereceived within second component 14. Second component 14 is operativelyconnected to third component 18 to allow the device to pass throughsecond component 14 and be received within third component 18. Base 16can include one or more ports, described, for example, in FIGS. 4a-d ,which can serve to connect first component 12 and second component 14and/or second component and third component 18. In some embodiments, oneor more of the components can be constructed or suitably joined to forma single monolithic component. For example, in some embodiments, secondcomponent 14 and third component 18 are a single monolithic component.In some embodiments, first component 12 and second component 14 are asingle monolithic component. In some embodiments, first component 12,second component 14, and third component 18 are a single monolithiccomponent.

First component 12, second component 14, and third component 18 can befluidly connected to tank unit 20 and pump 22 to simulate fluid flowwithin system 10. In some embodiments, the fluid can be human blood oranimal blood. In certain embodiments, the blood has been processed, forexample, to remove clotting factors. In some embodiments, system 10 canhave a closed flow path for fluid. In some embodiments, the fluid can bewater, which can, for example, be used to simulate blood. In someembodiments and as described further herein, one or more hemostats,clamps, and/or valves can be used to adjust pressures and flow rateswithin system 10. In some embodiments, one or more components of system10 can be immersed or otherwise disposed within a volume of fluid whenfully assembled.

System 10 can allow assessment of various measures which can be relevantto percutaneous aortic valve (PAV) procedures, such as hemodynamicperformance (e.g., pressures, cardiac output, paravalvular leakage andthe like). System 10 can additionally or alternatively be used fortraining. Such training can include, for example, assessment of coronaryocclusion and flow, as well as implant positioning parameters such asplacement depth, rotational orientation, vascular dissection and/oranterior mitral leaflet interference.

In some embodiments, the system can be used as a training tool in thefield. In some embodiments, the system can be used for plannedinterventional procedures. In some embodiments, the system can be usedto simulate procedures for relatively difficult or unusual cases. Forexample, in cases where uncommon anatomy is known to be present, asimulator corresponding to such anatomy can be used. One example of suchan uncommon anatomy can include certain cases of aortic valvereplacement. For example, approximately 1-2% of the population have twoaortic valve cusps rather than three aortic valve cusps. One or morecomponents of system 10 can be configured to simulate such uncommonanatomy.

In some embodiments, system 10 can be used to simulate one or morepercutaneous delivery procedures. In some percutaneous techniques, avalve prosthesis can be compacted and loaded onto a delivery device foradvancement through a patient's vasculature. In some embodiments, system10 can allow for simulation of illiofemoral, apical, direct aortic, andsubclavianiaxillary entry locations in a single apparatus. System 10 canbe configured to allow access from multiple locations per procedure(e.g. bilateral femoral access). In some embodiments, system 10 cansimulate a delivery of a valve prosthesis, such as a heart valveprosthesis, through an artery or vein, a femoral artery, a femoral vein,a jugular vein, a subclavian artery, an axillary artery, an aorta, anatrium, and/or a ventricle. System 10 can simulate a delivery of a valveprosthesis via a transfemoral, transapical, transseptal, transatrial,transventrical, or transaortic procedure.

In some embodiments, a heart valve prosthesis that can be used in asimulated delivery with system 10 can include a frame that supports aprosthetic valve body. The valve body can be formed, for example, fromone or more a biocompatible synthetic materials, synthetic polymers, anautograft tissue, homograft tissue, xenograft tissue, or one or moreother suitable materials. The valve body can be formed, for example,from bovine, porcine, equine, ovine, and/or other suitable animaltissues. The valve body can be formed, for example, from heart valvetissue, pericardium, and/or other suitable tissue. The valve body cancomprise one or more valve leaflets, for example, the valve body may bea tri-leaflet bovine pericardium valve, a bi-leaflet valve, or anothersuitable valve.

System 10 can be used to simulate a transfemoral delivery procedure. Inone example of a transfemoral delivery procedure in vivo, a deliverydevice in the form of a valve prosthesis can be advanced in a retrogrademanner through a patient's femoral artery and into the patient'sdescending aorta. A catheter can then be advanced under fluoroscopicguidance over the simulated aortic arch, through the ascending aorta,into the left ventricle, and mid-way across the defective aortic valve.Once positioning of the catheter is confirmed, the delivery device candeploy the valve prosthesis within the valve annulus. The valveprosthesis can then expand against the simulated annulus. In someembodiments, as the valve prosthesis is expanded, it can trap leafletsagainst the annulus, which can retain the native valve in a permanentlyopen state. In system 10, first component 12 can simulate a patient'saccess anatomy and femoral artery. Second component 14 can simulate thepatient's descending aorta, aortic arch, and a portion of the ascendingaorta. Third component 18 can simulate a portion of the patient'sascending aorta, as well as the left ventricle, aortic valve, and valveannulus.

In some embodiments, system 10 can simulate a transapical deliveryprocedure. In one example of a transapical procedure in vivo, a trocaror overtube can be inserted into a patient's left ventricle through anincision created in the apex of the patient's heart. A dilator can beused to aid in the insertion of the trocar. In this approach, the nativevalve (for example, the mitral valve) can be approached downstreamrelative to blood flow. The trocar can be retracted sufficiently torelease the self-expanding valve prosthesis. The dilator can bepresented between the leaflets. The trocar can be rotated and adjustedto align the valve prosthesis in a desired alignment. The dilator can beadvanced into the left atrium to begin disengaging the proximal sectionof the valve prosthesis from the dilator. In some transapicalembodiments, one or more components, such as for example secondcomponent 14 can be omitted and third component 18 can be directlyfluidly connected to another component, which can provide a closed fluidloop for system 10.

In some embodiments, system 10 can simulate a transatrial deliveryprocedure. In one example of a transatrial procedure in vivo, a dilatorand trocar can be inserted through an incision made in the wall of theleft atrium of the heart. The dilator and trocar can then be advancedthrough the native valve and into the left ventricle of heart. Thedilator can then be withdrawn from the trocar. A guide wire can beadvanced through the trocar to the point where the valve prosthesiscomes to the end of the trocar. The valve prosthesis can be advancedsufficiently to release the self-expanding frame from the trocar. Thetrocar can be rotated and adjusted to align the valve prosthesis in adesired alignment. The trocar can be withdrawn completely from the heartsuch that the valve prosthesis self-expands into position and can assumethe function of the native valve.

In some embodiments, one or more components of the system can beportable. In some embodiments, the entire system can be portable. Insome embodiments, the components of system 10 can be disassembled andpackaged together, which can allow for easy transport of system 10 to atraining site or other location. In some embodiments, system 10 can betransported in a hand-carried case of approximately 1 cubic meter orless. In some embodiments, one or more of the components can beassembled and form a semi-permanently or permanently assembled systemthat is not portable. In some embodiments, system 10 can be assembledfor use on a table top.

In some embodiments, system 10 can include conduits, such as conduits40, 46, 50, 52, and 56 (shown in FIG. 1 and/or FIG. 2) and valves, suchas valves 48 and 54, which can fluidly connect one or more of thecomponents. In some embodiments, the conduits can be in the form ofquick-connect fittings. In some embodiments, one or more of thecomponents can be connected via one or more tubing connections.

In some embodiments, the use of multiple components to be assembledtogether can allow for the components to be independently cleaned and/orsterilized. For example, in some embodiments, one component can beconstructed from a different material than another component and mayrequire different cleaning and/or sterilization techniques. In someembodiments, one or more components of system 10 can be cleaned and/orsterilized together while assembled.

In some embodiments, one or more components of system 10 are in the formof interchangeable parts. As merely one example, in some embodiments,third component 18 can include a simulated heart valve with 3 leaflets,whereas in some embodiments, third component 18 can include a simulatedheart valve with 2 leaflets. In some embodiments, the use ofinterchangeable parts can allow for easy and quick modification ofsystem 10 to allow for various configurations and/or alternativeconditions. As another example, an interchangeable component identicalto third component 18 can be used to allow repeated training on a singleconfiguration. In some embodiments, first component 12 can beinterchangeable. In some embodiments, second component 14 can beinterchangeable.

In some embodiments, one or more of the components can be secured orattached through various types of fasteners. For example, secondcomponent 14 can be attached to third component 18 with cable ties. Theattachment can be performed by a rapid tensioning tool. In some cases,such table ties can be easily cut and discarded to allow one or morecomponents of system 10 to be removed. In some embodiments, one or morecomponents of system 10 can be removed and replaced to allow for aprocedure to be repeated.

In some embodiments, one or more components or portions of thecomponents can be partially or completely transparent. In someembodiments, this can allow for one or more portions of the procedure tobe visualized by an operator or observer. Some embodiments of the systemcan allow for one or more portions of the system to be visualized usingfluoroscopy or other suitable visualization techniques. In someembodiments, a procedure can be visualized and performed underfluoroscopy with dye contrast.

FIG. 2 is a schematic flow diagram of system 10. FIG. 2 diagrams pump22, third component 18, a first tank 36, and a second tank 38 (firsttank 36 and second tank 38 together make up tank unit 20 shown in FIG.1), as well as various valves, conduits, and junctions disposedtherebetween. As shown in FIG. 2, a conduit 40, which can be in the formof a pump hose, connects pump 22 to first tank 36 at port 37 located onfirst tank 36 and a first end of third component 18 via a T-junction 42.In some embodiments, conduit 40 can simulate a left atrium of a humanheart.

A one-way valve 44 can be disposed between first tank 36 and pump 22. Insome embodiments, valve 44 can be configured to simulate a mitral valve.Valve 44 can, for example, be a Medtronic Hall® brand single leafletmechanical prosthetic valve (developed by Medtronic, Inc.). In someembodiments, a suture ring can be removed from such a valve, in somecases, this can allow valve 44 to be mounted directly and permanentlyinto a bottom surface of the tank. Any suitable valve design can beused. For example, a suitable mitral or aortic valve replacement,including a bi-leaflet design or tri-leaflet design, could be used. Insome embodiments, a mechanical valve can be used. In some embodiments,system 10 can include an extended plug that can cover the orifice ofvalve 44 when desired.

In some embodiments, a top end of first tank 36 can be left open to theatmosphere. Conduit 40 can be connected to another conduit 46 via valve48, which can serve as a “fast pace” bypass conduit. In someembodiments, valve 48 can be closed to simulate normal cardiac outputand opened when desired to simulate a reduction in cardiac outputpossible for a “fast pacing” mode. That is, when valve 48 is open, itcan simulate reduced pressure and cardiac output from a ventricle, whichcan hydrodynamically simulate fast pacing of a human heart. An outputend of third component 18 can be fluidly connected to first tank 36 aswell as second tank 38 via respective conduits 50 and 52. Conduit 52 canconnect to second tank 38 via port 53. In some embodiments, second tank38 is sealed and can include a valve 54 which can allow an operator toincrease or decrease an amount of fluid and/or pressure within secondtank 38. In some embodiments, second tank 38 can be fluidly connected tofirst tank 36 via conduit 56. A valve 58 can be located along conduit 56can be a valve 58 which can restrict the flow between second tank 38 andfirst tank 36.

FIGS. 3a-d illustrate various views of first component 12. FIG. 3aillustrates a front perspective view of first component 12. FIG. 3billustrates a front view of first component 12. FIG. 3c illustrates atop view of first component 12. FIG. 3d illustrates a right side view offirst component 12. In some embodiments, first component 12 can beshaped to simulate anatomy. In some embodiments, first component 12 isnot shaped to simulate anatomy.

In some embodiments, first component 12 can simulate a patient's accessanatomy and femoral artery. For example, first component 12 can allowfor the introduction of a device such as a delivery catheter to system10. First component 12 can be operatively connected to base 16 to allowthe device to pass through first component 12 and be received withinbase 16. In some embodiments, first component 12 can be connected tosecond component 14 without passing through base 16. In someembodiments, first component 12 can include a port 60 fluidly connectedto first tank 36 and pump 22 and a second port 62 fluidly connected to aport on base 16.

First component 12 can be in the form of a simulated leg model or otherdesired anatomy. One embodiment of a suitable leg model is shown forexample in FIG. 3. In some embodiments, first component 12 can representthe continuation of a patient's descending aorta inferior to thoracicaorta. As illustrated, first component 12 can be generally curved andelevated at one end 64, which can correspond to an inferior directiontowards a patient's legs.

In some embodiments, first component 12 can include one or more inletports, such as introducer ports 24 and 66, which can represent separatelocations for introduction of separate devices, such as a guidewire andseparate delivery catheter. In some embodiments, introducer ports 24 and66 can model left and right femoral arteries as separate introductionsites. In some embodiments, first component 12 can include a tray, whichcan for example be in the form of a small open tank, which can be placedunder introducer ports 24 and 66. In some embodiments, the tray cancollect small amounts of water that may drip from the ports. In someembodiments, a tray can be integrated into the first component 12.

In some embodiments, first component 12 can include one or more openings68 and 70, which can be configured to hold excess lengths of guidewire.In some embodiments, first component 12 can include one or more legs 72,which can support first component 12 and/or elevate first component 12to a desired height or angle. In some embodiments, one or more legs 72of first component 12 can be adjustable in length.

FIGS. 4a-d illustrate various views of a base 16. FIG. 4a illustrates afront perspective view of base 16. FIG. 4b illustrates a right side viewof base 16. FIG. 4c illustrates a top view of base 16. FIG. 4dillustrates a front view of base 16. Base 16 can be configured tosupport second component 14 as well as fluidly connect second component14 to first component 12 and tank unit 20.

Base 16 can include a port 74 that can fluidly connect second component14 to first component 12. In some embodiments, base 16 can include ports76 and 78 that connect portions of second component 14 to respectiveconduits 46 and 50. In some embodiments, base 16 can include supportsfor supporting second component 14.

FIGS. 5a-d illustrate a second component 14. FIG. 5a illustrates a frontperspective view of second component 14. FIG. 5b illustrates a left sideview of second component 14. FIG. 5c illustrates a front view of secondcomponent 14. FIG. 5d illustrates a top view of second component 14. Insome embodiments, second component 14 can be shaped to simulate anatomy.In some embodiments, second component 14 is not shaped to simulateanatomy. In some embodiments, second component 14 can simulate a portionof a patient's ascending aorta 80, as well as the descending aorta 82,and aortic arch 84. In some embodiments, a fluid outlet 86 can branchoff from the descending aorta 82 and can be fluidly connected to asealed tank, such as second tank 38 (in some embodiments), which in someembodiments can result in a simulation of arterial pressure.

In some embodiments, second component 14 is a thoracic aorta model andcan include one or more portions simulating an ascending aorta, aorticarch, descending thoracic aorta, and/or related arteries.

In some embodiments, second component 14 can include one or moresimulated arteries or outlets. In some embodiments, the arteries oroutlets can be blocked off, which in some cases can allow for a simplersimulation. For example, in some embodiments, a brachiocephalic artery88 and/or left common carotid artery 90 can be blocked off. In someembodiments, second component 14 can include one or more open arteriesor portions thereof. For example, in some embodiments, second component14 can include a simulated left subclavian artery 92.

In some embodiments, second component 14 can include a fluid outlet 94that is fluidly connected to port 74 in base 16 and a fluid outlet 98that is fluidly connected to third component 18.

In some embodiments, second component 14 can include a base 100 whichcan be configured to connect to base 16. In some embodiments, secondcomponent 14 can include one or more legs 102, which can support secondcomponent 14 and/or elevate second component 14 to a desired height orangle. In some embodiments, one or more legs 102 of second component 14can be adjustable in length.

FIGS. 6a-c illustrate two embodiments of a third component. FIG. 6aillustrates a front perspective view of third component 18. FIG. 6billustrates a front perspective view of another embodiment of a thirdcomponent 18 having an alternative shape to the embodiment of FIG. 6a .FIG. 6c illustrates a rear perspective view of the third component 18 ofFIG. 6b . In some embodiments, third component 18 is substantiallyhollow with relatively thin walls. In some embodiments, third component18 can be shaped to simulate anatomy. In some embodiments, thirdcomponent 18 can be based on the anatomy of a human cadaver. In someembodiments, third component 18 is not shaped to simulate anatomy.

In some embodiments, third component 18 includes a fluid outlet 109 thatfluidly connects to port 78 of base 16. In some embodiments, thirdcomponent 18 includes a fluid outlet 111 that fluidly connects to port74 of base 16.

In some embodiments, third component 18 can be in the form of ananatomically correct flexible model of a left ventricle and aortic root(“LVAR”). In some embodiments, third component 18 can simulate anascending aorta portion 107, as well as a left ventricle, aortic valve,and valve annulus. In some embodiments, third component 18 can include asinus portion 104. In some embodiments, third component 18 can includeone or more coronary arteries 106 and 108. In some embodiments, thirdcomponent 18 can include a simulated version of the left side of theheart. Other portions of the heart or other anatomy can be used.

In some embodiments, third component 18 is constructed entirely orpartially of a flexible material. In some embodiments, the flexiblematerial can be a medical grade silicone (for example, NUSIL brand gradeMED 10-6400 available from NuSil Technology LLC of Carpenteria, Calif.,USA). In some embodiments, this material can have a durometer hardnessmeasure of 30.

FIGS. 7a-d illustrate various views of tank unit 20. FIG. 7a illustratesa front perspective view of tank unit 20. FIG. 7b illustrates a top viewof tank unit 20. FIG. 7c illustrates a left side view of tank unit 20.FIG. 7d illustrates a rear view of tank unit 20.

In some embodiments, tank unit 20 can include first tank 36 and secondtank 38 disposed within a common housing 110. In some embodiments, firsttank 36 and second tank 38 are disposed within separate housings. Firsttank 36 and second tank 38 can be separated by a wall 112 to preventfluid from passing therebetween. In some embodiments, and as shown forexample in FIG. 2, first tank 36 and second tank 38 can be fluidlyconnected via a conduit, such as conduit 56, or a port to allow fluid topass therebetween if desired. Conduit 56 can include a valve 58, whichcan be in the form of an adjustable pinch clamp, which can restrict flowbetween first tank 36 and second tank 38. In some embodiments, a lowerend 114 of first tank 36 is elevated relative to a lower end of secondtank 38.

In some embodiments, first tank 36 can be open to the atmosphere at itsupper end, as shown for example in FIG. 7a . Such a configuration canallow conduits within system 10, such as conduit 46 (which can allow forfast pacing) and conduit 50 (which can allow for variable back pressure)to be easily connected to first tank 36. First tank 36 can receivereturn flow from one or more conduits at its upper end and can beconnected to a leg of T-junction 42 at its lower end through valve 44.In some embodiments, valve 44 can be disposed flush or nearly flush withthe bottom surface of first tank. In some embodiments, valve 44 can beintegrated with T-junction 42. In some embodiments, valve 44 andT-junction 42 can be separate components.

In some embodiments, one or both of first tank 36 and second tank 38 caninclude a drain valve (not illustrated in FIGS. 7a-d ). The drain valvecan be closed for filling one or both of the tanks and can be opened todrain one or both of the tanks.

In some embodiments, second tank 38 can be sealed to the atmosphere. Insome embodiments, second tank 38 can function similar to a Windkessel,(which some in the art liken to an elastic reservoir that can providevariable compliance). In some embodiments, an amount of compliance ofsecond tank 38 can be adjusted by adjusting an amount of fluid in secondtank 38. In some embodiments, valve 58, which as described above can bein the form of an adjustable pinch clamp, can provide variable backpressure. In some embodiments, tank unit 20 can allow for accuratesimulations of different hypertensive states of the body, such as forexample systole and diastole.

In some embodiments, system 10 can include a pump 22. In someembodiments, pump 22 can be configured to ensure that an adequate amountof fluid is present before pump 22 operates. For example, pump 22 caninclude a float and/or a flow switch or other suitable devices.

The size and type of pump 22 can be selected to provide pressure andstroke volume in accordance with a desired simulation. For example, pump22 can be a motor-driven reciprocating piston pump. In some embodiments,such a piston pump can allow for a flow of fluid in system 10 toregularly reverse direction. In some embodiments, pump 22 can be a pulseduplicator. In some embodiments, pump 22 can be a “Harvard pump”, whichis manufactured by Harvard Apparatus division of Harvard BioscienceCompany. In some embodiments, pump 22 can be configured to provide aconstant stroke volume. In some embodiments, a pump case of pump 22 canbe waterproof. In some embodiments, pump 22 can include forward andreverse flow timing values of 50% each. In some embodiments, the timingvalues are not adjustable.

In some embodiments, system 10 can include one or more heaters to heatfluid within system 10. In some embodiments, pump 22 can include anintegrated heater. In some embodiments, a heating control system can becontained inside a pump case of pump 22. One or more heaters can be usedfor example, to raise temperature of fluid within the system to a rangeof approximately 85° to approximately 100° F. In some embodiments, oneor more of the components themselves can be heated to simulate a desiredbody temperature or other temperature.

In some cases, if the water is heated to simulate blood temperature,system 10 can include one or more resistance heaters in first tank 36.In some embodiments, such heaters can have sufficient capacity to heat adesired volume of available water to a desired temperature range in anacceptably brief time. In some embodiments, system 10 include additionalor alternative heating devices. In some embodiments, system 10 caninclude one or more thermostatic temperature control and/or one or morethermometers which can indicate and/or control a fluid temperature. Insome embodiments, pulsatile flow (including, if present, the heatedfluid) can accurately replicate in vivo conditions of flow rate,pressure, and temperature. In some embodiments, each of these parameterscan be adjusted or controlled to improve the accuracy of the simulation.

In some embodiments, a power supply can be used to operate pump 22.Suitable power supplies can include, for example, 120 VAC at 60 Hz or240V at 50 Hz. In some embodiments, the power supply can power both apump as well as one or more additional components of system 10. Forexample, a power supply can power a heater for heating fluid within tankunit 20. In some embodiments, a cardiac beat rate of system 10 can beset by a rate of pump 22. In some embodiments, a cardiac beat rate canbe set by another device. In some embodiments, a cardiac output can beaffected by one or more of total compliance, back pressure and strokevolume of pump 22. In some embodiments, pump speeds of 60 beats perminute to 100 beats per minute can be provided. This can allow forsimulation of the following blood pressure states (per ISO 5840:2005definitions for the left side heart): Normotensive (100 to 130 over 65to 85 mmHg), Hypotensive (60 over 40 mmHg), Hypertensive Stage 1 (mild)(140 to 159 over 90 to 99 mmHg), Hypertensive Stage 2 (moderate) (160 to179 over 100 to 109 mmHg), Hypertensive Stage 3 (severe) (180 to 209over 110 to 119 mmHg).

System 10 can be configured to allow for simulated conditions ofprocedures. Examples of such simulated conditions can include simulatedanatomy, body temperature, and/or hemodynamic parameters. In someembodiments, one or more of the internal surfaces of one or morecomponents of system 10 can be treated to simulate the “feel” of aprocedure. For example, system 10 can use water as a system fluid ratherthan actual blood. Although the fluid properties of water and blood aresimilar, the fluid properties are not identical. Given at least thesedifferences between the simulation and an in vivo environment, the“feel” of the movement and placement of a device within the vasculatureduring a simulated procedure might not result in the same “feel” as anactual in vivo procedure even if the device itself is an actualimplantable product.

In some embodiments, one or more components of system 10, such as thirdcomponent 18, can be constructed from a silicone material. Some types ofsilicone material can be tacky as a result of relatively highcoefficients of friction or other causes. Actual vasculature in apatient does not exhibit such tackiness. Therefore, in some embodiments,one or more internal surfaces of one or more components of system 10 caninclude a coating of material, such as for example silicone, liquidsilicone rubber (LSR), or a suitable composition containing glass beads.In some cases, such a material can reduce tackiness and/or frictionwithin the component. For example, in some embodiments, an inner surfaceadjacent to a simulated aortic valve is coated with such a material toreduce the surface friction. In some embodiments, the vasculaturedownstream of the valve, and also the regions where the vasculature istortuous, such as the aortic arch to the aortic valve are coated in sucha material. In some embodiments, regions where a delivery catheter wouldchange direction from a linear path are coated in such a material.

In some embodiments, system 10 is configured to simulate the effects ofcalcification within the vasculature. For example, componentsmanufactured by stereolithography can be configured to replicate acalcification profile and have that profile integrated a component ofthe system. In some embodiments, the stereolithography process can use arelatively rigid resin-based polymer. In some embodiments, thestereolithography process can use a semi-rigid polymer or othermaterial.

In some embodiments, system 10 is configured to use anatomically-baseddelivery pathways between an access site and a target implant targetlocation. In some embodiments, this can include a simulated functioningnative valve and anatomy distal to the target implant location withwhich a delivery device can interact. In some embodiments, this canprovide for a highly accurate simulation and training experience.

In some embodiments, system 10 is configured to allow for relativelyeasy removal of transcatheter valve implants from the anatomy. In someembodiments, this can allow for training to be rapidly repeated. In someembodiments, removal/restart cycle times can be on the order of 3-5minutes.

The choice of materials for the components of the various physiologicsimulator systems described herein can be informed by the requirementsof mechanical properties, temperature sensitivity, biocompatibility,moldability properties, or other factors apparent to a person havingordinary skill in the art. For example, one or more of the components(or a portion of one of the components) can be made from suitableplastics, such as a suitable thermoplastic, suitable metals, and/orother suitable materials. One or more components of system 10 can beconstructed entirely or partially of a flexible material. In someembodiments, the flexible material can be a medical grade silicone (forexample, NUSIL brand grade MED 10-6400 available from NuSil TechnologyLLC of Carpenteria, Calif., USA). In some embodiments, one or morecomponents can be constructed entirely or partially of actual human oranother animal's anatomy. As merely one example, in some embodimentsleft subclavian artery 92 can be constructed partially or entirely froman actual human or another animal's left subclavian artery. In someembodiments, mammalian tissue (e.g., porcine aorta and heart, humancadaver heart) can be incorporated into one or more of the components.

Although this application describes a system 10 that can allow forcertain procedures to be conducted with certain products, it should benoted that similar procedures for other products can be simulated bymodifying the disclosed embodiments in accordance with known principles.For example, a lower pressure right side of a heart can be simulated bymodifying system 10 to provide one or more of reduced back pressure,greater Windkessel volume, and less stroke volume. In some embodiments,this can obtain a wide variety of pressure states for the right side ofthe heart. Such configurations can allow for simulated implants ofreplacement pulmonary and/or tricuspid valves, or other proceduresrelevant to the anatomy of the right side of the heart.

In another example, a technique that can be used to bypass blockages ina left anterior descending coronary artery is revascularization via aleft interior mammary artery (LIMA). Some embodiments of system 10 canenable training of procedures and/or devices for coronaryrevascularization and/or other interventional vascular procedures (e.g.,endovascular abdominal aortic aneurysm grafting).

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Other modifications and variations can be possible in light of the aboveteachings. The embodiments and examples were chosen and described inorder to best explain the principles of the invention and its practicalapplication and to thereby enable others skilled in the art to bestutilize the invention in various embodiments with modifications as aresuited to the particular use contemplated. It is intended that theappended claims be construed to include other alternative embodiments ofthe invention.

What is claimed is:
 1. A system for the simulation of a percutaneousmedical procedure, the system comprising: a simulated vasculatureincluding a first component configured to allow for introduction of amedical device into the system through an introductory port, a secondcomponent connected to the first component and shaped to simulate aportion of a human vasculature, and a third component connected to thesecond component and shaped to simulate a delivery site for thesimulated percutaneous medical procedure; a pump for pumping fluidthrough the simulated vasculature to simulate blood flow during thesimulated percutaneous medical procedure; and a tank unit fluidlyconnected to the pump, wherein the tank unit includes a first tank thatis unsealed and open to the atmosphere and a second tank that is sealedand not open to the atmosphere, wherein the system is configured toallow for a medical device to be delivered to the third component bypassing through the introductory port of the first component and passingthrough the second component, and wherein the system is configured toreplicate simulated conditions of use for the simulated percutaneousmedical procedure, wherein the simulated conditions of use includesimulated hemodynamic properties for the simulated percutaneous medicalprocedure.
 2. The system of claim 1, wherein the simulated conditions ofuse further include simulated anatomy shape and size for the simulatedpercutaneous medical procedure.
 3. The system of claim 1, wherein thefirst component is in the form of a simulated leg model to correspond toanatomy for the simulated percutaneous medical procedure.
 4. The systemof claim 1, wherein the first component includes a portion correspondingto a femoral artery to correspond to anatomy for the simulatedpercutaneous medical procedure.
 5. The system of claim 1, wherein thesecond component includes a portion in the form of an aortic archcorresponding to anatomy for the simulated percutaneous medicalprocedure.
 6. The system of claim 1, wherein the second component is inthe form of a descending aorta, aortic arch, and a portion of theascending aorta corresponding to anatomy for the simulated percutaneousmedical procedure.
 7. The system of claim 1, wherein a portion of thethird component is in the form of an aortic valve corresponding toanatomy for the simulated percutaneous medical procedure.
 8. The systemof claim 1, wherein the third component is in the form of leftventricle, aortic valve, valve annulus, and a portion of the ascendingaorta corresponding to anatomy for the simulated percutaneous medicalprocedure.
 9. The system of claim 1, wherein the simulated conditions ofuse further include simulated body temperature for the simulatedpercutaneous medical procedure.
 10. The system of claim 9, wherein oneor more of the components of the system are heated to simulate a desiredbody temperature for the simulated percutaneous medical procedure. 11.The system of claim 9, wherein the fluid is heated to simulate a desiredbody temperature for the simulated percutaneous medical procedure. 12.The system of claim 1, wherein the simulated conditions of use furtherinclude simulated tackiness of one or more of the components tocorrespond to components of the simulated percutaneous medicalprocedure.
 13. The system of claim 12, wherein an inner surface of oneor more of the components is coated with a material to reduce frictionof the inner surface.
 14. The system of claim 13, wherein the innersurface is coated with silicone.
 15. The system of claim 1, wherein thefluid is water for simulating blood for the simulated percutaneousmedical procedure.
 16. The system of claim 1, wherein the fluid isblood.
 17. The system of claim 1, wherein the pump is configured tosimulate fluid pressure within the system.
 18. The system of claim 17,wherein the pump is configured to simulate one or more blood pressurestates.
 19. The system of claim 1, wherein the tank unit is configuredto provide variable back pressure for one or more components in thesystem.
 20. The system of claim 19, wherein the second tank has avariable compliance and includes a valve configured to permit anoperator to vary an amount of fluid or pressure within the second tankin order to vary an amount of compliance of the second tank.
 21. Thesystem of claim 19, wherein the second component is fluidly connected tothe first tank and the second tank and wherein the second tank isfluidly connected to the first tank via a conduit having a valvetherein, the valve being configured to restrict the flow between thefirst tank and the second tank to provide a desired back pressure to thesecond component.
 22. The system of claim 19, wherein the secondcomponent is fluidly connected to the first and second tanks and thesecond component is connected to the first tank via a conduit that isvertically oriented and sized to provide a desired back pressure to thesecond component.
 23. The system of claim 1, wherein the simulatedpercutaneous medical procedure is a catheter-based implant procedure.24. The system of claim 1, wherein the simulated percutaneous medicalprocedure is a catheter-based heart valve replacement procedure.
 25. Thesystem of claim 1, wherein the second component and the third componentare a single monolithic component.
 26. The system of claim 1, whereinthe first component and the second component are a single monolithiccomponent.
 27. The system of claim 1, wherein the first component, thesecond component, and the third component are a single monolithiccomponent.
 28. The system of claim 1, wherein the first componentincludes legs that are sized to elevate the first component to a desiredheight or angle.
 29. The system of claim 1, wherein the second componentincludes legs that are sized to elevate the second component to adesired height or angle.
 30. The system of claim 1, wherein one or moreof the components of the system is at least partially constructed ofartificial materials.
 31. The system of claim 1, wherein one or morecomponents of the system is at least partially constructed from actualanatomy.
 32. The system of claim 1, wherein one or more components ofthe system is transparent.
 33. The system of claim 1, wherein one ormore components of the simulated vasculature is configured to bedisassembled and reassembled.
 34. The system of claim 1, wherein thesystem is assembled for use on a table top.
 35. The system of claim 1,wherein the simulated hemodynamic properties include a normal cardiacoutput and a reduced cardiac output.
 36. A method of simulating apercutaneous medical procedure using a simulated vasculature including afirst component configured to allow for introduction of a medical deviceinto the system through an introductory port, a second componentconnected to the first component and shaped to simulate a portion of ahuman vasculature, a third component connected to the second componentand shaped to simulate a delivery site for the simulated percutaneousmedical procedure, the method comprising: inserting the medical deviceinto the introductory port of the first component; advancing the medicaldevice through the first component and into the second component;advancing the medical device through the second component and into thethird component; and pumping fluid through the simulated vasculature tosimulate blood flow during the simulated percutaneous medical procedurevia a pump, wherein a tank unit is fluidly connected to the pump and thepump and the tank unit are configured to replicate simulated hemodynamicproperties during the simulated percutaneous medical procedure, the tankunit including a first tank that is unsealed and open to the atmosphereand a second tank that is sealed and not open to the atmosphere.
 37. Themethod of claim 36, further comprising: delivering the medical devicewithin the third component.
 38. The method of claim 36, wherein thesimulated percutaneous medical procedure simulates a transfemoraldelivery procedure.
 39. The method of claim 36, wherein the simulatedpercutaneous medical procedure simulates a transapical deliveryprocedure.
 40. The method of claim 36, wherein the simulatedpercutaneous medical procedure simulates a transatrial deliveryprocedure.
 41. The method of claim 36, wherein the simulatedpercutaneous medical procedure is a catheter-based implant procedure andthe medical device includes a catheter.
 42. The method of claim 37,further comprising: retracting the medical device from the simulatedvasculature.
 43. The method of claim 36, further comprising: varying aback pressure to the second component during the simulated percutaneousmedical procedure.
 44. The method of claim 36, further comprising:varying a cardiac output to one or more components during the simulatedpercutaneous medical procedure.